510(k) · Cleared
ClearedOrthadapt Bioimplant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pegasus Biologics, Inc. · FTM Mesh, Surgical
Cleared on May 4, 2007 as substantially equivalent to K043388 (Pegasus Biologics, Inc., 2005) after an 18-day review. Its family tree reaches back 7 generations to 1992. 44 later devices descend from it.
- Decided
- May 4, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921895 (1992). 26 ancestors in all, the oldest K830889 (1983). 44 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 3 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 2 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 1 generation backK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005
- This deviceK071065 Orthadapt BioimplantPegasus Biologics, Inc. · 2007
- Descendant · cites it directly · 28 of its ownK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- Descendant · cites it directly · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · 3 generations on · 10 of its ownK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- Descendant · 2 generations on · 9 of its ownK192112 FlexBand PlusInternational Life Sciences · 2019
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007 · cites it directly28descendants
- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · cites it directly12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 2 generations on11descendants
- K131143Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013 · 3 generations on10descendants
- K192112FlexBand PlusInternational Life Sciences · 2019 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −3 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −1 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | — |
| 0 (this device) | K071065 | Orthadapt Bioimplant | Pegasus Biologics, Inc. | 2007 | — |
| +1 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| +1 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +2 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +3 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| +2 | K192112 | FlexBand Plus | International Life Sciences | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043388 | Pegasus Biologics Orthadapt Surgical MeshSummary page 1…ially equivalent to the OrthADAPT® Bioimplant (Surgical Mesh) manufactured by Synovis Orthopedic and Woundcate, Inc. and cleared for commercial distribution under 510(k) K043388. 4 Device Description The OrthADAPT Bioimplant is a decellularized, equine pericardium. The OrthADAPT Bioimplant has been cross… | 2005 |
What descends from it? (44)
See all 446 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071887 | Sportmesh or Artelon Tissue Reinforcement | 2007 | 28 |
| K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6… | 2008 | 12 |
| K090288 | Orthadapt PR | 2009 | 7 |
| K111584 | Xylos Macro-Porous Surgical Mesh | 2011 | 5 |
| K080353 | LTM-T Surgical Mesh | 2008 | 4 |
| K113460 | Synergy Tissue Matrix | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K071887 (Artimplant AB, 2007) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K043388.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and other reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff…
Read the full statement (134 words)
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
OrthADAPT® is intended for one-time use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071065: Orthadapt Bioimplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071065
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026